Adapalene Swab
NDC Package 49908-118-14

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Adapalene swabs is a medication used to treat acne. This formulation utilizes a swab delivery system. Marketed by Call Inc. (dba Rochester Pharmaceuticals), this product is identified by NDC 49908-118 and is authorized under FDA application ANDA204593.

Identification & Billing

NDC Package Code
49908-118-14
Package Description
14 POUCH in 1 CARTON / 1.2 mL in 1 POUCH (49908-118-00)
Product Code
49908-118
11-Digit Billing Format
49908011814
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Adapalene
Non-Proprietary Name
Adapalene
Substance Name
Adapalene
Dosage Form
Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
ADAPALENE 1 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

Regulatory & Marketing

Labeler Name
Call Inc. (dba Rochester Pharmaceuticals)
Product Type
Human Prescription Drug
FDA Application #
ANDA204593
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-04-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49908-118-14 identifies a specific commercial package of 14 pouch in 1 carton / 1.2 ml in 1 pouch (49908-118-00) of Adapalene, a human prescription drug labeled by Call Inc. (dba Rochester Pharmaceuticals). This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This swab is formulated for topical use and contains adapalene as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Call Inc. (dba Rochester Pharmaceuticals) on February 04, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

How is this Call Inc. (dba Rochester Pharmaceuticals) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49908011814. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49908-118-14
11-Digit CMS (5-4-2)
49908-0118-14

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.